UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039888
Receipt number R000045491
Scientific Title Impact of sacopenia and activities of daily living in patients with hip fractures
Date of disclosure of the study information 2020/03/20
Last modified on 2020/03/20 11:26:16

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Basic information

Public title

Impact of sacopenia and activities of daily living in patients with hip fractures

Acronym

Impact of sacopenia and ADL in patients with hip fractures

Scientific Title

Impact of sacopenia and activities of daily living in patients with hip fractures

Scientific Title:Acronym

Impact of sacopenia and activities of ADL in patients with hip fractures

Region

Japan


Condition

Condition

femoral neck fracture

Classification by specialty

Orthopedics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between the actual condition of sarcopenia and ADL at discharge in patients with proximal femoral fracture.

Basic objectives2

Others

Basic objectives -Others

Sarcopenia accounts for approximately 20 ~ 50% of proximal femoral fractures and is associated with a high risk of QOL deterioration and frailty. Therefore, rehabilitation requires not only measures against functional impairment but also measures against sarcopenia.
However, the status of sarcopenia in the perioperative period and the relationship between sarcopenia and rehabilitation outcome are unclear. In this study, we investigated the actual condition of sarcopenia and factors affecting ADL in patients with proximal femoral fracture.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Barthel index efficacy

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients aged 65 years or older undergoing surgery and postoperative rehabilitation at our hospital for proximal femoral fracture

Key exclusion criteria

Patients with serious complications who were unable to walk or died before the injury

Target sample size

42


Research contact person

Name of lead principal investigator

1st name Takako
Middle name
Last name Nagai

Organization

Nihon university hospital

Division name

Orthpedic surgery

Zip code

101-8309

Address

1-6, kanda surugadai, Chiyoda-ku,Tokyo

TEL

03-3293-1711

Email

ntnyf092@yahoo.co.jp


Public contact

Name of contact person

1st name Takako
Middle name
Last name Nagai

Organization

Nihon University hospital

Division name

Orthpedic surgery

Zip code

101-8309

Address

1-6, kanda surugadai, Chiyoda-ku,Tokyo

TEL

03-3293-1711

Homepage URL


Email

ntnyf092@yahoo.co.jp


Sponsor or person

Institute

Nihon University hospital

Institute

Department

Personal name



Funding Source

Organization

Nihon University hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University hospital

Address

1-6, kanda surugadai, Chiyoda-ku,Tokyo

Tel

03-3293-1711

Email

ntnyf092@yahoo.co.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

42

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 06 Month 01 Day

Date of IRB

2019 Year 12 Month 12 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

There were 28 patients in the sarcopenia group and 14 patients in the non-sarcopenia group. Univariate analysis revealed significant differences in age, body weight, body mass index (BMI), and dementia. In the correlation between BI gain and each value in Spearman's rank correlation coefficient, GNRI and BI at discharge showed positive correlation, and negative correlation in age, sarcopenia, CCI, PIMs, and cognitive function. Multiple regression analysis using BI at discharge as the dependent variable revealed that age and PIMs were significant associated factors.


Management information

Registered date

2020 Year 03 Month 20 Day

Last modified on

2020 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045491


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name